BEUDAMED
    FDA Recall Terminated

    i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ

    Recall: Z-1996-2010 · Initiated May 5, 2010

    Recall

    Recall Number
    Z-1996-2010
    Event Number
    55895
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2010
    Posted
    July 13, 2010
    Terminated
    September 22, 2011
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ

    Reason

    A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received.

    Action

    Urgent recall notifications were sent on May 13 2010. Customers were instructed to discontinue use and to return the identified lots. Additional questions are directed to Abbott Point of Care Technical Support at 800-3668020, Option 1 or your Abbott Point of Care representative.

    Distribution

    Worldwide distribution: Argentina, Hong Kong, China, Finland, Greece, India, Portugal, Russian Federation, Saudi Arabia, United Arab Emirates, Italy, Spain, Australia, Germany, UK, Sweden, The Netherlands, France, Canada.

    Quantity

    44976 in US, 3648 in rest of world.